Thousands sue over implant

Camera IconRuth de Smit is part of one of the biggest class-action lawsuits filed in Australia.

A controversial implant approved by Australia’s medicines watchdog has been accused of butchering up to 4000 Australian women, leaving them in permanent pain.

A Federal parliamentary inquiry is being negotiated to examine the safety of the mesh device and its approval by the Therapeutic Goods Administration without clinical testing.

In a class action against —pharmaceutical giant Johnson & Johnson, thousands of women will seek hundreds of millions of dollars in compensation for disabilities allegedly caused by the surgical mesh.

The action, led by Shine Lawyers, could dwarf the $250 million settlement Johnson & Johnson paid last year over its DePuy hip implant.

Australia's health regulator has found women with breast implants are at higher risk of breast cancer than first thought

The West Australian

VideoAustralia's health regulator has found women with breast implants are at higher risk of breast cancer than first thought

The mesh has been implanted in 100,000 Australian women since 2000 to overcome side effects of childbirth and urogynaecological issues. Medical reviews claim up to one in eight women suffer complications.

Australia’s TGA still allows surgeons to implant the mesh despite bans, warnings and product withdrawals in other countries and up to 100,000 pending lawsuits in the US.

Senator Derryn Hinch will push for a Senate inquiry into the use of the mesh and claims the TGA approved it without pre-market clinical testing.

“I believe this is the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s when kids were born without arms and legs,” Senator Hinch said.

The TGA began monitoring the mesh’s use in 2008 as global concerns emerged but ruled complications were low and linked to surgeons’ skills rather than faulty devices.

After a warning by the US Food and Drug Administration and the withdrawal of products by Johnson & Johnson in 2012, the TGA launched a more extensive clinical review in 2013 of about 100 devices registered for use in Australia. All but 23 were delisted between August 2014 and November 2015.

“The TGA has implemented increased pre-market scrutiny for all applications for these devices,” it said in a statement.

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has warned against the polypropylene mesh’s use for pelvic prolapse because of insufficient testing and concerns of devastating complications but believes it is effective and safe to treat continence conditions.

Perth woman Ruth de Smit has spent 10 “miserable” years and endured seven operations trying to rid herself of the mesh but even now can still feel it.

The 67-year-old said that if she had known of the nightmare ahead — debilitating pain and bleeding — she would have put up with the minor prolapse issues she suffered after having three children.

She is one of dozens of WA women who have joined the class action, many told their continuing pain was because nerves had grown into the eroding mesh.

Ms de Smit started having problems within months of her implant in 2006, with her doctor telling her that the severe pain was “because the mesh had come undone”.

Doctors have tried to remove all the mesh but she can still feel rigid pieces of it inside her.

Another Perth woman said she had been left so incapacitated by the pain she was unable to leave her house. “My nerves are constantly on fire,” she said.

A 72-year-old Perth grandmother said the mesh device she had implanted in 2007 had ruined her life but she had been told it was impossible to remove.